No significant differences in AEs or discontinuation due to AEs between groups; Diarrhea was more common in 6mg than placebo (P = 0.007) but not in 2mg (P = 0.1516 vs. placebo); most common AEs were headache and abdominal pain; both were more common among placebo.

AE incidence was similar for all groups (56.3% vs. 57.1% vs. 59.6% for 2mg, 6mg, and placebo); most common AE was headache which was more common with placebo (10.1% vs. 11% vs. 13.2%); only diarrhea was significantly different between groups (6.6% for 6mg vs. 3.0% for placebo; P = 0.0005)

No notable differences in AEs compared to short- term treatment; only half of patients completed the extension study; discontinuation reasons: 19.3% lack of efficacy, 11% withdrawal of consent; 6.3% AEs; headache and abdominal pain were the most common AEs; diarrhea in 2.0–8.5%

Diarrhea (10% vs. 3.1%) and abdominal pain (5.8% vs. 3.1%) were more frequent with tegaserod; other AE frequencies were similar; headache was most common AE (12% tegaserod vs. 11.1% placebo); discontinuation due to diarrhea in 2.3% of tegaserod; serious AEs (1.5% vs. 3.4%); more SAEs in the placebo group; no deaths

More overall AEs with tegaserod (55% vs. 50%); headache was the most frequently reported AE overall (8.0% vs. 4.7%); diarrhea more frequent with tegaserod (9.2% vs. 1.3%) and led to discontinuation in 2.8% of tegaserod group; 1 death in the tegaserod group due to acute myocardial infarction

Only diarrhea was reported significantly more frequently with tegaserod (3.8% vs. 0.6%; P < 0.0001); headache was the most common AE reported (5.5% vs. 5.0%; P NS); discontinuations due to AEs were similar; no deaths